Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01379703
First received: June 22, 2011
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: August 9, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1 Patients

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tablets and Capsules or Oral Solution HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Participant Flow for 2 periods

Period 1:   Study Start Through 9 Months
    Tablets and Capsules or Oral Solution   Capsule Formulation   Tablet Formulation
STARTED   66 [1]   1206 [2]   1016 [3] 
COMPLETED   62   1084 [4]   873 
NOT COMPLETED   4   122   143 
Lost to Follow-up                2                61                104 
Adverse Event                0                14                10 
Withdrawal by Subject                0                6                1 
Treatment Failure                0                2                2 
Patient Noncompliance                0                0                1 
Tuberculosis/TB treatment                0                4                0 
Medication not available                0                2                1 
Poor general condition                0                1                0 
Increased triglycerides                0                1                0 
Reason unknown                2                31                24 
[1] Participants taking lopinavir/ritonavir tablets/capsules or oral solution during the study (66/2288)
[2] Participants taking the lopinavir/ritonavir capsule formulation (only) during study (1206/2288)
[3] Participants taking the lopinavir/ritonavir tablet formulation (only) during study (1016/2288)
[4] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).

Period 2:   9 Months Through 18 Months
    Tablets and Capsules or Oral Solution   Capsule Formulation   Tablet Formulation
STARTED   0 [1]   1084 [2]   0 [1] 
COMPLETED   0   854   0 
NOT COMPLETED   0   230   0 
Lost to Follow-up                0                178                0 
Withdrawal by Subject                0                11                0 
Adverse Event                0                6                0 
Treatment failure                0                5                0 
Patient Noncompliance                0                4                0 
Tuberculosis/TB treatment                0                2                0 
Fatigue                0                1                0 
Reason Unknown                0                23                0 
[1] Participants in this subgroup were followed for 9 months.
[2] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.

Baseline Measures
   Total Study Population 
Overall Participants Analyzed 
[Units: Participants]
 2288 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (11.0) 
Gender, Customized 
[Units: Participants]
 
Female   867 
Male   1419 
Data not reported   2 
Region of Enrollment 
[Units: Participants]
 
Serbia   149 
Czech Republic   107 
Slovenia   123 
Slovakia   26 
Poland   381 
Ukraine   266 
Romania   422 
Lithuania   3 
Russian Federation   644 
Israel   139 
Georgia   10 
Latvia   18 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   CD4 Count   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title CD4 Count
Measure Description CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2220   1165   993 
CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
     
Mean CD4 count   229.9  (194.2)   208.8  (187.2)   246.8  (194.8) 

No statistical analysis provided for CD4 Count



2.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 1 month ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 1 month  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change from baseline analysis is based on participants with CD4 count results available at 1 month.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 670   348   293 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
     
Mean CD4 count at 1 month   288.7  (185.1)   277.1  (195.7)   296.1  (172.1) 
Change in CD4 count   60.3  (137.4)   54.9  (158.3)   70.6  (113.8) 

No statistical analysis provided for Changes in CD4 Count



3.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 3 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 3 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change from baseline analysis is based on participants with CD4 count results available at 3 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1633   838   738 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
     
Mean CD4 count at 3 months   323.9  (219.3)   310.1  (227.9)   332.4  (206.7) 
Change in CD4 count   94.5  (162.9)   97.7  (188.7)   93.2  (123.9) 

No statistical analysis provided for Changes in CD4 Count



4.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 6 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 6 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change from baseline analysis is based on participants with CD4 count results available at 6 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1533   780   699 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
     
Mean CD4 count at 6 months   361.5  (248.9)   333.4  (219.8)   382.0  (271.7) 
Change in CD4 count   124.4  (197.6)   117.1  (182.5)   131.6  (216.0) 

No statistical analysis provided for Changes in CD4 Count



5.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 9 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 9 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change from baseline analysis is based on participants with CD4 count results available at 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1410   713   645 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
     
Mean CD4 count at 9 months   384.1  (221.4)   363.5  (222.2)   395.0  (209.0) 
Change in CD4 count   151.5  (174.4)   144.8  (191.7)   156.0  (151.5) 

No statistical analysis provided for Changes in CD4 Count



6.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 12 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 12 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 729 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
 
Mean CD4 count at 12 months   392.0  (216.5) 
Change in CD4 count   170.4  (201.7) 

No statistical analysis provided for Changes in CD4 Count



7.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 15 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 15 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 701 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
 
Mean CD4 count at 15 months   412.6  (240.5) 
Change in CD4 count   194.8  (228.5) 

No statistical analysis provided for Changes in CD4 Count



8.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 18 months ]

Measure Type Primary
Measure Title Changes in CD4 Count
Measure Description Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Time Frame Baseline to 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 599 
Changes in CD4 Count 
[Units: Cells per mm³]
Mean (Standard Deviation)
 
Mean CD4 count at 18 months   429.7  (249.4) 
Change in CD4 count   222.2  (228.7) 

No statistical analysis provided for Changes in CD4 Count



9.  Primary:   Viral Load   [ Time Frame: Baseline ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1572   739   781 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
     
Mean viral load   4.44  (1.26)   4.49  (1.17)   4.43  (1.31) 

No statistical analysis provided for Viral Load



10.  Primary:   Viral Load   [ Time Frame: 1 month ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 1 month  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 420   218   175 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 3.28  (1.08)   3.42  (1.07)   3.19  (1.04) 

No statistical analysis provided for Viral Load



11.  Primary:   Viral Load   [ Time Frame: 3 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 3 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 995   469   478 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 2.69  (1.00)   2.86  (0.97)   2.54  (1.00) 

No statistical analysis provided for Viral Load



12.  Primary:   Viral Load   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 6 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1093   506   544 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 2.40  (0.89)   2.62  (0.88)   2.21  (0.84) 

No statistical analysis provided for Viral Load



13.  Primary:   Viral Load   [ Time Frame: 9 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 9 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 918   406   471 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
     
Mean viral load at 9 months   2.41  (0.96)   2.65  (1.02)   2.24  (0.88) 
Change in viral load   -2.05  (1.42)   NA [1]   -2.21  (1.44) 
[1] Change from baseline LOCF analysis for participants receiving capsule formulation was performed at 18 months.

No statistical analysis provided for Viral Load



14.  Primary:   Viral Load   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 12 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 444 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 2.54  (0.92) 

No statistical analysis provided for Viral Load



15.  Primary:   Viral Load   [ Time Frame: 15 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 15 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 432 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 2.49  (0.92) 

No statistical analysis provided for Viral Load



16.  Primary:   Viral Load   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Viral Load
Measure Description Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Time Frame 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 413 
Viral Load 
[Units: Log10 copies per ml]
Mean (Standard Deviation)
 
Mean viral load at 18 months   2.35  (0.84) 
Change in viral load   -1.95  (1.42) 

No statistical analysis provided for Viral Load



17.  Primary:   Laboratory Parameter Blood Glucose   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Blood Glucose
Measure Description Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 1831   875   899 
Laboratory Parameter Blood Glucose 
[Units: Millimoles per liter]
Mean (Standard Deviation)
     
Baseline   4.87  (2.05)   4.89  (2.83)   4.85  (0.86) 
9 months   4.92  (1.42)   4.87  (1.38)   4.99  (1.49) 
18 months   NA [1]   5.07  (2.64)   NA [1] 
[1] Only participants who received lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Blood Glucose



18.  Primary:   Laboratory Parameter Transaminases   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Transaminases
Measure Description Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2288   1206   1016 
Laboratory Parameter Transaminases 
[Units: International units per liter]
Mean (Standard Deviation)
     
AST - Baseline   38.9  (37.1)   36.8  (32.1)   41.4  (42.4) 
AST - 9 months   35.2  (33.0)   34.8  (29.6)   36.0  (36.9) 
AST - 18 months   NA [1]   36.4  (30.8)   NA [1] 
ALT - Baseline   41.0  (40.3)   39.6  (38.7)   42.6  (42.6) 
ALT - 9 months   39.8  (52.5)   40.8  (44.8)   39.0  (60.3) 
ALT - 18 months   NA [1]   42.0  (44.8)   NA [1] 
[1] Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Transaminases



19.  Primary:   Laboratory Parameter Lipids   [ Time Frame: Baseline, 9 months, 18 months ]

Measure Type Primary
Measure Title Laboratory Parameter Lipids
Measure Description A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Time Frame Baseline, 9 months, 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2288   1206   1016 
Laboratory Parameter Lipids 
[Units: Millimoles per liter]
Mean (Standard Deviation)
     
Total Cholesterol - Baseline   4.37  (1.50)   4.48  (1.68)   4.28  (1.35) 
Total Cholesterol - 9 months   4.96  (1.81)   5.07  (2.36)   4.89  (1.25) 
Total Cholesterol - 18 Months   NA [1]   5.01  (1.29)   NA [1] 
HDL Cholesterol - Baseline   1.39  (0.84)   2.17  (1.45)   1.19  (0.44) 
HDL Cholesterol - 9 months   1.53  (0.98)   2.08  (1.64)   1.32  (0.53) 
HDL Cholesterol - 18 months   NA [1]   2.04  (1.94)   NA [1] 
LDL Cholesterol - Baseline   2.50  (1.07)   2.87  (1.10)   2.29  (1.02) 
LDL Cholesterol - 9 months   2.73  (1.07)   3.11  (1.18)   2.51  (0.95) 
LDL Cholesterol - 18 months   NA [1]   3.09  (1.14)   NA [1] 
Triglycerides - Baseline   1.65  (1.06)   1.66  (1.11)   1.64  (1.04) 
Triglycerides - 9 months   2.20  (1.46)   2.21  (1.49)   2.17  (1.44) 
Triglycerides - 18 months   NA [1]   2.13  (1.35)   NA [1] 
[1] Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

No statistical analysis provided for Laboratory Parameter Lipids



20.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 9 months ]

Measure Type Secondary
Measure Title Reasons for Discontinuation of Lopinavir/Ritonavir
Measure Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 9 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2288   1206   1016 
Reasons for Discontinuation of Lopinavir/Ritonavir 
[Units: Participants]
     
Number of participants discontinued   269   122   143 
Lost to Follow-up   167   61   104 
Adverse Event   24   14   10 
Withdrawal by Subject   7   6   1 
Treatment failure   4   2   2 
Other - Tuberculosis/TB treatment   4   4   0 
Other - Medication not available   3   2   1 
Other - Poor general condition   1   1   0 
Other - Increased triglycerides   1   1   0 
Patient Noncompliance   1   0   1 
Reason unknown   57   31   24 

No statistical analysis provided for Reasons for Discontinuation of Lopinavir/Ritonavir



21.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Reasons for Discontinuation of Lopinavir/Ritonavir
Measure Description For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Time Frame 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 1206 
Reasons for Discontinuation of Lopinavir/Ritonavir 
[Units: Participants]
 
Number of participants discontinued   352 
Lost to Follow-up   239 
Adverse Event   20 
Withdrawal by Subject   17 
Treatment failure   7 
Other - Tuberculosis/TB treatment   6 
Patient Noncompliance   4 
Other - Medication not available   3 
Other - Fatigue   1 
Other - Increased triglycerides   1 
Reason unknown   54 

No statistical analysis provided for Reasons for Discontinuation of Lopinavir/Ritonavir



22.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 9 months ]

Measure Type Secondary
Measure Title Compliance With Lopinavir/Ritonavir
Measure Description Participants reported whether they had missed doses of their antiretroviral treatment.
Time Frame 9 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2288   1206   1016 
Compliance With Lopinavir/Ritonavir 
[Units: Participants]
     
Reported never missing a dose   1377   729   616 
Reported missing one or more doses   853   459   361 
Information not reported   58   18   39 

No statistical analysis provided for Compliance With Lopinavir/Ritonavir



23.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Compliance With Lopinavir/Ritonavir
Measure Description Participants reported whether they had missed any doses of their antiretroviral treatment.
Time Frame 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.

Reporting Groups
  Description
Capsule Formulation Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.

Measured Values
   Capsule Formulation 
Participants Analyzed 
[Units: Participants]
 1206 
Compliance With Lopinavir/Ritonavir 
[Units: Participants]
 
Reported never missing a dose   616 
Reported missing one or more doses   578 
Information not reported   12 

No statistical analysis provided for Compliance With Lopinavir/Ritonavir



24.  Secondary:   Adverse Events Observed on Treatment With Lopinavir/Ritonavir.   [ Time Frame: 18 months ]

Measure Type Secondary
Measure Title Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Measure Description

Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.

All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.

Time Frame 18 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Measured Values
   Total Study Population   Capsule Formulation   Tablet Formulation 
Participants Analyzed 
[Units: Participants]
 2288   1206   1016 
Adverse Events Observed on Treatment With Lopinavir/Ritonavir. 
[Units: Events]
     
Total number of AEs with causal relationship   260   175   78 

No statistical analysis provided for Adverse Events Observed on Treatment With Lopinavir/Ritonavir.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
Study First Received: June 22, 2011
Results First Received: August 9, 2011
Last Updated: October 10, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Slovenia: Ethics Committee
Slovak Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health